LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm

Inclusion Criteria:

1. Subject must be at least 21 years of age and at least the minimum Age of Majorityaccording to applicable state law.

2. Underwent primary index procedure of laparoscopic repair of a hiatal hernia largerthan 3 cm with placement of a LINX® device or construction of a fundoplication forreflux control more than 2 years prior to his/her enrollment or has completed 1 or 2of the barium swallows and GERD-HRQLs within study time points with or withouthiatal hernia recurrence.

3. Subject is willing and able to cooperate with follow-up examinations.

4. Subject has been informed of the study procedures and treatment and has signed aninformed consent.

Exclusion Criteria:

1. The surgical procedure was completed as an emergency procedure

2. Currently being treated with another investigational drug or investigational device

3. Suspected or confirmed esophageal or gastric cancer

4. Subject has Barrett's esophagus >3cm

5. Cannot understand trial requirements or is unable to comply with follow-up schedule

6. Pregnant or plans to become pregnant during the course of the study

7. Medical illness (i.e. congestive heart failure) that may cause the subject to benon-compliant with or able to meet the protocol requirements or is associated withlimited life expectancy (i.e. less than 3 years)

8. Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects thatexhibit depression that are on appropriate medication(s) are allowable.