Obalon Balloon System Pivotal IDE (SMART) Trial

Inclusion Criteria:

1. Male or female between the ages of 22-64 years

2. Current BMI of 30.0 - 40 kg/m2

3. Previously attempted to lose weight unsuccessfully using a medically supervised or
non-medically supervised diet

4. Willing to attend all protocol-specified follow-up visits plus any additional
follow-up visits as required throughout the entire study period

5. Willing to avoid non-commercial air travel and scuba diving during the entire study
period

6. Willing to avoid medications or other substances known to effect weight changes during
the study

7. Willing to avoid Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or other medications
known to be gastric irritants during the study

8. Willing to use contraception and avoid pregnancy during the study if the subject is
female with child bearing potential

9. Willing to provide written informed consent

Exclusion Criteria:

1. Significant weight loss in the past 12 months

2. Use of medications or other substances known to induce weight gain or weight loss

3. Participation in any clinical study at the start of this trial or in the last year

4. Known history of endocrine disorders affecting weight

5. Currently receiving chronic steroid or immunosuppressive therapy or has previously
been diagnosed with HIV

6. Subjects diagnosed with bulimia, binge eating, compulsive overeating, high liquid
calorie intake habits or similar eating related psychological disorders

7. Intent to undergo gastric surgery or gastric banding during the study period or within
the 6 month period after completion of this study

8. Prior use of any weight loss medical device

9. Known history of structural or functional disorders of the esophagus

10. Known history of structural or functional disorder of the esophagus, including any
swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal
reflux symptoms

11. Known history of structural or functional disorders of the stomach

12. Known history of a structural or functional disorder of the stomach, including any
symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic
dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or
pain, post-prandial nausea or vomiting or early satiety

13. Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal
varices, intestinal stricture/stenosis, small bowel obstruction, or any other
obstructive disorder of the gastrointestinal (GI) tract

14. Currently have ongoing symptoms suggestive of intermittent small bowel obstruction,
such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting

15. Known history irritable bowel syndrome, radiation enteritis or other inflammatory
bowel disease, such as Crohn's disease

16. Known history of GI surgeries that may have resulted in anatomical GI tract
abnormalities

17. Type 1 diabetes

18. Type 2 diabetes requiring insulin or other hypoglycemic oral agents.

19. Experienced a myocardial infarction, has a known history of angina, a known history of
congestive heart failure, or is currently being medically treated for any other
cardiac condition

20. Poorly controlled hypertension, (≥ 160 mmHg Systolic and ≥ 100mmHg Diastolic).

21. End stage renal disease or requiring hemodialysis within the past 6 months

22. Unwilling or unable to avoid Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including
Aspirin, Diclofenac, Ibuprofen, Naproxen, or other medications known to be gastric
irritants beginning two weeks prior to enrollment and throughout the entire study
period

23. Subjects taking medications on specified hourly intervals that may be affected by
changes to gastric emptying

24. Subjects requiring the use of anti-platelet drugs or other agents affecting the normal
clotting of blood

25. Untreated or unstable alcohol or illicit drug addiction

26. Known history of allergies to any component of the device materials

27. Currently pregnant or breastfeeding or intention of becoming pregnant during the study

28. Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical
condition, in the opinion of the investigator

29. Subject is employed by the investigator, or is a close relative of the investigator,
or the investigator's staff

30. Subject is a close relative of another subject already enrolled in the study.

31. Any other condition that, in the opinion of the investigator, would interfere with
subject participation, may confound the study results, or interfere with compliance
with the study (e.g., psychosocial issues).