A Prospective, Multi-Center, Longitudinal Cohort Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus (LCS Dysplasia)

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.