Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus

The study will consist of an estimated 200 subjects with HGD or LGD within BE who are deemed
inoperable or refuse standard surgical treatment. A maximum of 20 investigational sites will
participate with a maximum of ten subjects per site.

Inclusion Criteria:

- Karnofsky performance status of 50-100%

- Life expectancy greater than 5 years

- Hematopoietic, Hepatic and Renal lab clearance

- Previous endoscopy with histological confirmation of LGD or HGD within BE

- For Group 2, deemed inoperable based on the following criteria: co-morbid conditions
such as severe heart, lung, kidney or liver disease; or refusal of surgical
intervention after a thorough unbiased discussion of surgery.

- For Group 2, endoscopic ultrasound (EUS) evaluation demonstrating no evidence of
invasion or metastatic lymph node involvement (T0N0M0 by EUS).

Exclusion Criteria:

- Pregnant, not practicing adequate contraception, intending to become pregnant, or
lactating at any time during the study (approximately 2 years).

- Esophageal stricture preventing passage of endoscope or catheter.

- Active esophagitis

- EMR performed less than 8 weeks prior to CSA treatment.

- EMR performed on greater than 90% circumference of any area of the esophagus.

- Any previous esophageal surgery, except fundoplication without complications.

- Known history of unresolved drug or alcohol dependency that would limit ability to
comprehend or follow instructions related to informed consent, post-treatment
instructions, or follow-up guidelines.

- Concurrent enrollment in an investigational drug or device trial that clinically
interferes with the LCS Dysplasia endpoints.

- Psychiatric or other illness deemed by the investigator as an inability to comply with
this protocol.

- Medically unfit or other contraindication to tolerate upper endoscopy.

- Inability to tolerate therapy with a proton pump inhibitor (PPI).

- Refusal or inability to give consent.

- Other active malignancy (except nonmelanoma skin cancer or another cancer for which
patient is deemed disease-free).

- Concurrent chemotherapy.

- Prior radiation therapy which involved the esophagus.

- Prior adenocarcinoma involving the esophagus or stomach.

- Prior or concurrent ablation therapy including, but not limited to, photodynamic
therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment,
radio frequency, etc.