This registry is intended as an observational, post-marketing surveillance tool. The registry allows collection of baseline demographics and user experience of the commercially available MUSE system. Data collection aims to aggregate a minimum of 3 years follow-up on a large number of subjects during use outside the constraints of a prescribed clinical study.

The registry evaluates the MUSE System which creates a transoral anterior fundoplication for the treatment of GERD. The system enables the operator to staple the fundus of the stomach to the esophagus approximately 3cm superior to the Z-line in 2 or more locations. The procedure is performed transorally under general anesthesia. The procedural result is anatomically and functionally similar to standard anterior fundoplication (Dor-Thal operation). The staples are standard, 4.8mm titanium surgical staples. Each application of the device fires a quintuplet of staples (5) in three staggered rows. Anti-retching medications at the time of the procedure are essential.

The study population will be primarily adults aged 18-70 years selected by the investigators based on SAGES guidelines for fundoplication and consideration of the indications and contraindications listed in the device Instructions for Use (IFU).

Follow-up data will be collected at 6 months, 1, 2 and 3 years post procedure.

Inclusion Criteria:

Generally follow the guidelines for Laparoscopic Fundoplication published by SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) Objective evidence of GERD

• Positive acid exposure test or endoscopic evidence of esophagitis AND
• Inadequate symptom control or
• Patient preference from surgery over medications or
• Extra-esophageal manifestations (asthma, hoarseness, cough, chest pain, aspiration)

Exclusion Criteria:

• Significant co-morbidity (for example, American Society of Anesthesiologists Grade 3 or higher)
• BMI >35 or <20
• No response to proton pump inhibitors
• Grade IV esophagitis
• Hiatal hernia >3 cm
• Irreducible hernia of any size
• Gastric outlet obstruction
• Short esophagus
• Esophageal diverticula, strictures or varices
• Esophageal motility disorders

The registry population will consist of adult subjects diagnosed with GERD who are deemed suitable for the procedure by the investigator given the information provided in the instructions for use.