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

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.