A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects

The ReShape Post Approval Study is a post-approval, multicenter, single arm, open label
clinical study intended to collect valid scientific evidence regarding the safety and
efficacy of the ReShape Dual Balloon as an adjunct to diet and exercise in the treatment of
BMI 30-40 subjects with one or more obesity-related comorbid conditions in a commercial
clinical setting.

Inclusion Criteria:

1. Ages 22 and older

2. Baseline BMI 30 - 40

3. Failed weight reduction with diet and exercise alone

4. One or more obesity-related comorbid conditions

5. If female of child bearing potential, willing to avoid pregnancy during course of
treatment

Exclusion Criteria:

1. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive
peritonitis or known abdominal adhesions

2. Prior open or laparoscopic bariatric surgery.

3. Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric
ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's
disease.

4. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric
varices, congenital or acquired intestinal telangiectasis, or other congenital
anomalies of the gastrointestinal tract such as atresias or stenoses.

5. A gastric mass.

6. A hiatal hernia > 5 cm or ≤ 5 cm with associated severe or intractable
gastro-esophageal reflux symptoms.

7. A structural abnormality in the esophagus or pharynx such as a stricture or
diverticulum that could impede passage of the delivery catheter and/or an endoscope.

8. Achalasia or any other severe esophageal motility disorder that may pose a safety risk
during the removal of the device

9. Severe coagulopathy

10. Hepatic insufficiency or cirrhosis

11. Serious or uncontrolled psychiatric illness or disorder that could compromise patient
understanding of or compliance with follow up visits and removal of the device after 6
months.

12. Alcoholism or drug addiction.

13. Patients unwilling to participate in an established medically-supervised diet and
behavior modification program, with routine medical follow-up.

14. Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents,
anticoagulants or other gastric irritants.

15. Patients who are unable or unwilling to take prescribed proton pump inhibitor
medication for the duration of the device implant.

16. Patients who are known to have, or suspected to have, an allergic reaction to
materials contained in the system.

17. Patients who have ever developed a serotonin syndrome and are currently taking any
drug known to affect the levels of serotonin in the body [e.g., selective serotonin
reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs),
monoamine oxidase inhibitors (MAOIs)] should not undergo placement of the device.

18. Patients who are pregnant or breast-feeding.

19. Significant endoscopic abnormalities immediately prior to device insertion.