HALO Patient Registry: Ablation of Barrett's Esophagus

Summary The HALO Patient Registry provides a framework for treatment and follow-up of
patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD). The primary objective is
to provide a tool for participating physician investigators to collect outcomes data related
to the use of the HALO Ablation Systems.

Protocol Design:

This is a prospective, multi-center patient Registry. Sites may choose to also
retrospectively enroll previously treated patients (after obtaining informed consent) and
enter retrospective data into case report forms on-line. "Retrospective data collection" is
defined as any data other than patient history collected prior to signing of the informed
consent. A set of case report forms (CRFs) is provided along with this protocol to track
outcomes. The CRFs may be completed and retained on site, but the site is recommended to
utilize the internet-based data entry system.

Inclusion Criteria:

- Must be a candidate for ablation of Barrett's esophagus with the HALO Ablation
System.

- Must agree to the proposed follow-up schedule and provide informed consent for
participation.

Exclusion Criteria:

- Pregnancy

- Prior radiation therapy to the esophagus

- Esophageal varices at risk for bleeding

- Prior Heller Myotomy